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Status unknownNCT01110798Updated Sep 17, 2013

J-Pouch Colorectal Anastomosis or Straight Colorectal Anastomosis in Treating Patients With Rectal Cancer Who Have Undergone Surgery to Remove the Tumor

An interventional study of intraoperative complication management/prevention and assessment of therapy complications in Colorectal Cancer, Gastrointestinal Complications and Perioperative/Postoperative Complications, sponsored by Azienda Ospedaliera di Padova. Status unknown at 4 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-17.

Sponsored by Azienda Ospedaliera di Padova · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

RATIONALE: It is not yet known whether a J-pouch colorectal anastomosis is more effective than a straight colorectal anastomosis in treating patients with rectal cancer who have undergone surgery to remove the tumor.

PURPOSE: This randomized clinical trial is studying J-pouch colorectal anastomosis to see how well it works compared with straight colorectal anastomosis in treating patients with rectal cancer who have undergone surgery to remove the tumor.

Read the detailed description

OBJECTIVES:

Primary

  • To assess whether the incidence of major anastomotic leak after low anterior resection, in patients with rectal cancer, is reduced by using the J-pouch reconstruction vs straight colorectal anastomosis.

Secondary

  • To compare the global anastomotic leak (major and minor) rate, the incidence of other complications in addition to anastomotic leak, and the functional outcome and the quality of life in these patients.
  • To describe, in the J-pouch reconstruction group, the feasibility of the colonic J-pouch.

OUTLINE: Ths is a multicenter study. Patients are stratified according to clinical center, gender (male vs female), and neoadjuvant treatment types. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo a total mesorectal excision with a low anterior rectal resection followed by a mechanical straight stapled colorectal anastomosis.
  • Arm II: Patients undergo a total mesorectal excision with a low anterior rectal resection followed by a mechanical J-pouch stapled anastomosis reconstruction.

Quality of life is assessed periodically using EORTC Quality of Life Questionnaires (EORTC QLQ-C30 and -CR38), and the MSKCC Bowel Function Questionnaire.

After completion of study treatment, patients are followed at 1, 6, 12, and 24 months.

02

Conditions studied

  • Colorectal Cancer
  • Gastrointestinal Complications
  • Perioperative/Postoperative Complications

Keywords

  • perioperative/postoperative complications
  • gastrointestinal complications
  • adenocarcinoma of the rectum
  • stage I rectal cancer
  • stage II rectal cancer
  • stage III rectal cancer
03

In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's planned enrollment of 600 is above the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Azienda Ospedaliera di Padova is the lead sponsor of 37 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed rectal adenocarcinoma meeting the following criteria:

    • Mid and/or low rectal cancer
    • Tumor site ≤ 11 cm from anal verge
    • Must have a temporary stoma (ileostomy or colostomy)
  • Must be scheduled for a total mesorectal excision with a low anterior rectal resection and mechanic colorectal anastomosis that is potentially curative or with a microscopic residual resection (R0-R1)
  • No locally recurrent disease
  • No distant metastasis

PATIENT CHARACTERISTICS:

  • Must be able to understand the study

PRIOR CONCURRENT THERAPY:

  • No prior handsewn coloanal anastomosis
  • No prior colonic resection
  • No prior surgery for local recurrence
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Masking
None (open label)
Enrollment
600 participants (estimated)

Interventions

  • Otherintraoperative complication management/prevention
  • Procedureassessment of therapy complications
  • Proceduregastrointestinal complications management/prevention
  • Procedurequality-of-life assessment
  • Proceduretherapeutic conventional surgery
06

What researchers measure

Primary outcomes

  1. Major anastomotic leak rate

Secondary outcomes

  1. Percentage of the colonic J-pouch reconstruction performed with respect to the total number of patients selected for the J-pouch treatment arm

  2. Global anastomotic leak rate

  3. Anastomotic complications rate in addition to anastomotic leak

  4. Bowel function, fecal incontinence, and quality of life, evaluated with validated questionnaires

07

Study locations

4 of 4 sites recruiting
  • Universita Degli Studi di Florence - Policlinico di Careggi
    Florence, 50134, Italy
    Recruiting
  • Fondazione Istituto Nazionale dei Tumori
    Milan, 20133, Italy
    Recruiting
  • Azienda Ospedaliera di Padova
    Padova, 35128, Italy
    Recruiting
  • Ospedale Civile Di San Vito Al Tagliamento
    San Vito Al Talgliamento, Italy
    Recruiting
08

References and documents

Publications

  • Gavaruzzi T, Pace U, Giandomenico F, Pucciarelli S, Bianco F, Selvaggi F, Restivo A, Asteria CR, Morpurgo E, Cuicchi D, Jovine E, Coletta D, La Torre G, Amato A, Chiappa A, Marchegiani F, Rega D, De Franciscis S, Pellino G, Zorcolo L, Lotto L, Boccia L, Spolverato G, De Salvo GL, Delrio P, Del Bianco P. Colonic J-Pouch or Straight Colorectal Reconstruction After Low Anterior Resection For Rectal Cancer: Impact on Quality of Life and Bowel Function: A Multicenter Prospective Randomized Study. Dis Colon Rectum. 2020 Nov;63(11):1511-1523. doi: 10.1097/DCR.0000000000001745. PubMed 33044292 ↗
  • Jakob MO, Haltmeier T, Candinas D, Beldi G. Biologic mesh implantation is associated with serious abdominal wall complications in patients undergoing emergency abdominal surgery: A randomized-controlled clinical trial. J Trauma Acute Care Surg. 2020 Dec;89(6):1149-1155. doi: 10.1097/TA.0000000000002877. PubMed 32649617 ↗
  • Pucciarelli S, Del Bianco P, Pace U, Bianco F, Restivo A, Maretto I, Selvaggi F, Zorcolo L, De Franciscis S, Asteria C, Urso EDL, Cuicchi D, Pellino G, Morpurgo E, La Torre G, Jovine E, Belluco C, La Torre F, Amato A, Chiappa A, Infantino A, Barina A, Spolverato G, Rega D, Kilmartin D, De Salvo GL, Delrio P. Multicentre randomized clinical trial of colonic J pouch or straight stapled colorectal reconstruction after low anterior resection for rectal cancer. Br J Surg. 2019 Aug;106(9):1147-1155. doi: 10.1002/bjs.11222. Epub 2019 Jun 24. PubMed 31233220 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01110798
Lead sponsor
Azienda Ospedaliera di Padova
First posted
Apr 27, 2010
Start date
Oct 2009
Primary completion
Oct 2011 (estimated)
Last update
Sep 17, 2013

Study contacts

Donato Nitti, MD
principal investigator · Azienda Ospedaliera di Padova
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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